In October 2010, iso 13485 consulting agreed to pay $268 million to settle Usa lawsuits and claims relevant to its Sprint Fidelis family of defibrillation leads recalled three years ago as a result of faulty wires. In 2009, the corporation estimated that at least 13 people may have died because of the problem. Situations such as this emphasize why standards have been set up, standards such as ISO 13485: 2003, that help medical device companies maintain quality assurance and manage risk.
Medical devices for example pacemakers and diabetic pumps could save countless lives, in addition they pose an enormous threat to human life if proper safety and quality procedures are certainly not followed. ISO 13485: 2003 solves two concerns for medical device manufacturers:
Supplying customers and end-users with safe medical products and superior patient outcomes
Based on the U.S. Department of Commerce’s International Trade Association, the medical devices marketplace is expected to grow to greater than $285 billion by the end of 2012. Medical device manufacturers need quality management systems to make certain quality, standardize manufacturing and make sure that their tools are safe for your end-user.
Many standards for example ISO 13485: 2003 are becoming the global standard for individuals who manufacture medical devices mainly because they provide a proven guideline for maintaining assurance and managing risk. The EU device directives require medical device companies to use a quality system consistent with this standard, and Canada requires device manufacturers marketing their goods in Canada to have a quality system certified to ISO 13485 or 13488. Adoption of the standard continues to be under consideration from the FDA.
ISO 13485: 2003, “specifies requirements for ohsas 18001 where a corporation must demonstrate being able to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”
The key word is consistently. Consistency helps to minimize errors.
Just how can consistency be achieved? The short solution is through documentation of processes, incorporating quality control into every step of the production process and utilizing a computerized quality management system.
The principal objective of this international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The standard is based on eight quality management principles: customer focus, leadership, involvement of folks, process approach, system strategy to management, continual improvement, fact-based decision-making and mutually beneficial supplier relationships.
Revised in 2003, ISO 13485: 2003 shifts the significance through the role of quality inspection at the end of production to responsibility for quality control throughout every aspect 28dexmpky production and builds quality assurance procedures to the process itself. The revised standard focuses on how well the corporation assesses and manages risk, identification and traceability, and cleanliness in the work environment.
Tha harsh truth? ISO 13485: 2003 can be a tool that reassures consumers that any hazards for them with the medical devices they might come in touch with are increasingly being managed using a systematic method of making the items safer for usage.
The important thing to this standard is e stewards certification that builds the real key themes of the standard into its processes in the beginning. As a result, medical device manufacturers can realize better product quality, cost-effectiveness and time to market.